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Safety
Important safety issues: In the safety assessment of the production and utilisation of a product containing high numbers of living microorganisms, several aspects must be considered and they fall into two broad categories:
• Potential health risk for humans during culture, formulation and use. Pathogenicity, toxicity and allergens must be considered, as must residues in plant products and foods. • The risk of negative effects on the environment. Here, the risk of pathogenicity or toxicity to organisms other than humans is considered. Information is also required on the survival and spread of the organism in the ecosystem and its effects on the natural diversity of microorganisms and on essential processes in the system. Safety is interconnected with legislation: The use of large-scale cultured microorganisms in technical applications is governed by the Swedish Environment Bill (1998:808). All microorganisms that could be considered of interest for the DOM programme fall within this definition. In addition, for some applications - e.g. biological control with microorganisms – EU directives and regulations prescribe thorough documentation and authorisation before marketing. Issues related to genetically modified microorganisms are governed by specific legislation and are not covered by the DOM programme. Central activitiesProgramme for testing effects on human health: A new test programme for an initial safety assessment of biotechnical microorganisms is designed and evaluated in DOM. It encompasses collection and evaluation of scientific literature and other information, in vitro testing of potential pathogenicity and production of toxic substances, determination of antibiotic resistance pattern, and temperature range for growth. After taking a microorganism through the programme, it will be possible to determine whether the organism is a good candidate for product development or if it has any characteristics that may give rise to problems. 
The ciliate (Tetrahymena pyriformis) that is used in the BACTOX method, in culture at the DOM laboratory.
Determining the fate of the microorganisms in the environment: To determine if an introduced microbe can have a negative impact in the environment, we need to know to what extent the population survives and whether it spreads outside the area of use. Therefore, we develop strain-specific genetic SCAR-markers that are used for specific detection and quantification of the abundance of the organisms. These studies also contribute to an evaluation of the risk for product residues on harvested plant products or on food after processing. Inventories of international regulations: Changes in the legislation governing the release onto the market and use of biotechnical microorganisms are actively monitored. This is particularly important since authorisation procedures within the EU are still under development and few products have yet been awarded final approval. The findings of the DOM programme are expected to result in advice on more efficient risk assessment in the authorisation of products containing biotechnological organisms and to provide guidance when new legislation is being drawn up. Personnel |